bioMerieux buys standards innovator BTF

By Dr Matt Wilkinson

- Last updated on GMT

Related tags Bacteria

Industrial microbiology expert bioMerieux has acquired Australian
firm BTF, strengthening its quality control (QC) and manufacturing
quality assurance (QA) offerings to the pharmaceutical industry.

The acquisition will see Sydney-based BTF become a subsidiary of bioMerieux, giving bioMerieux access to BTF's unique BioBall reference technology, strengthening its microbial testing portfolio.

Financial details of the deal to buy BTF, which had 2006 sales of AU$4m (€2.4m), were not disclosed.

According to Renaud Jonquieres, global marketing manager for pharmaceutical marketing, the BioBall technology will help pharmaceutical companies prove to regulatory bodies that their sterility controls and testing procedures are working correctly.

The accuracy of these procedures is vital as drug companies face significant penalties if the quality of their products does not comply with regulations.

Indeed, several major firms have been forced to close manufacturing facilities in recent years due to failed US Food and Drug Administration (FDA) inspections - a very costly exercise.

"The BioBall technology will help the QA/QC laboratories responsible for the quality of pharmaceutical products, by removing the need to prepare bacterial strains at accurate concentrations," said Jonquieres.

Each BioBall contains an accurate number of micro-organisms or colony forming units (cfu) measured out by flow cytometry methods which are then lyophilised into a form that can be stored frozen for up to 24 months.

This quantitative microbiological quality control tool will find applications in testing the quality of cell culture media being used in tests, method validation, accreditation compliance, multi-laboratory standardisation, proficiency schemes, determining uncertainty measurements and as a positive control for quantitative QC.

Another significant application for such a technique is in bioprocess development work, where downstream processing systems used to remove host bacteria from biologics need to be validated before they can be included in a process.

According to Jonquieres, the BioBall technology removes the need for laborious bacterial preparation tasks as a BioBall containing a specific strain and concentration can simply be mixed with culture media and then used as a reference to ensure the sterility of vaccines, pharmaceuticals and clean rooms.

"In the pharmaceutical industry one of the important concepts is trending - you need to demonstrate that there are no big shifts in bacterial concentrations from day-to-day and that there are no out-of-specification results" said Jonquieres.

"This simple tool gives laboratories a reproducible control to measure cell culture media and strain variability."

The BioBall's are supplied as either standard kits, or can be custom made to a users required specifications.

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